Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

668

Participants

Timeline

Start Date

December 17, 2013

Primary Completion Date

January 29, 2016

Study Completion Date

March 16, 2023

Conditions
Advanced, Metastatic Breast Cancer
Interventions
DRUG

Ribociclib

Ribociclib (600 mg, in three 200 mg hard gelatin capsules or tablets) was administered orally once daily on Days 1-21 of each 28-day cycle.

DRUG

Letrozole

Letrozole (2.5 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)

DRUG

Placebo

Placebo (hard gelatin capsules or tablets) was administered orally once daily on Days 1-21 of each 28-day cycle.

Trial Locations (221)

652

Novartis Investigative Site, Saida

1134

Novartis Investigative Site, Budapest

2610

Novartis Investigative Site, Wilrijk

3000

Novartis Investigative Site, Leuven

3002

Novartis Investigative Site, East Melbourne

3500

Novartis Investigative Site, Hasselt

4032

Novartis Investigative Site, Debrecen

5000

Novartis Investigative Site, Namur

5020

Novartis Investigative Site, Salzburg

5037

Novartis Investigative Site, Kurralta Park

5300

Novartis Investigative Site, La Rioja

5700

Novartis Investigative Site, Gyula

6009

Novartis Investigative Site, Nedlands

7100

Novartis Investigative Site, Vejle

9100

Novartis Investigative Site, Sint-Niklaas

10002

Novartis Investigative Site, Taipei

10016

NYU Langone Med Center CV Research, New York

10029

Mount Sinai School Of Medicine, New York

10060

Novartis Investigative Site, Candiolo

10330

Novartis Investigative Site, Bangkok

10408

Novartis Investigative Site, Gyeonggi-do

10467

Montefiore Medical Center, The Bronx

10999

Novartis Investigative Site, Beirut

11217

Novartis Investigative Site, Taipei

11501

Winthrop University Hospital, Mineola

12801

C R Wood Cancer Center at Glens Falls Hospital, Glens Falls

13620

Novartis Investigative Site, Bundang Gu

14169

Novartis Investigative Site, Berlin

14195

Novartis Investigative Site, Berlin

15706

Novartis Investigative Site, Santiago de Compostela

16132

Novartis Investigative Site, Genova

17033

Penn State Hershey Cancer Institute, Hershey

18103

Lehigh Valley Hospital, Allentown

20133

Novartis Investigative Site, Milan

21000

Novartis Investigative Site, Diyarbakır

21231

Sidney Kimmel CCC At JH, Baltimore

21701

Frederick Memorial Hospital, Frederick

22031

Virginia Cancer Specialists, Fairfax

23561

Novartis Investigative Site, New Taipei City

23900

Novartis Investigative Site, Lecco

24153

Oncology and Hematology Associates of Southwest Virginia Inc, Salem

25030

Novartis Investigative Site, Besançon

25123

Novartis Investigative Site, Brescia

27710

Duke Univ Medical Center, Durham

28009

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

30033

Georgia Cancer Specialists, Decatur

31792

Lewis Hall Singletary Onc Ctr at John D. Archbold Mem Hosp., Thomasville

32504

Sacred Heart Medical Oncology, Pensacola

32804

Florida Retina Institute, Orlando

33000

Novartis Investigative Site, Bordeaux

33021

Memorial Hospital, Hollywood

33081

Novartis Investigative Site, Aviano

33136

University Of Miami, Miami

33305

Novartis Investigative Site, Taoyuan District

33328

Florida Cancer Research Institute, Davie

33426

University Cancer Institute, Boynton Beach

33604

Novartis Investigative Site, Bielefeld

33705

Florida Cancer Specialists-North, St. Petersburg

33901

Florida Cancer Specialists, Fort Myers

35100

Novartis Investigative Site, Padua

Novartis Investigative Site, Istanbul

Novartis Investigative Site, Izmir

37203

Sarah Cannon Research Institute, Nashville

37232

Vanderbilt University Medical Ctr, Nashville

37404

Chattanooga Onc And Hem Assoc PC, Chattanooga

38320

Novartis Investigative Site, San Cristóbal de La Laguna

38642

Novartis Investigative Site, Goslar

39202

Jackson Oncology Associates, Jackson

40225

Novartis Investigative Site, Düsseldorf

41013

Novartis Investigative Site, Seville

42551

Novartis Investigative Site, Velbert

43221

The Ohio State University Comprehensive Cancer Center, Columbus

44805

Novartis Investigative Site, Saint-Herblain

45136

Novartis Investigative Site, Essen

45242

Oncology Hematology Care Inc, Cincinnati

45657

Novartis Investigative Site, Recklinghausen

46009

Novartis Investigative Site, Valencia

46063

Novartis Investigative Site, Liberec

46202

IU Simon Cancer Center, Indianapolis

46236

Novartis Investigative Site, Bottrop

49055

Novartis Investigative Site, Angers

52621

Novartis Investigative Site, Ramat Gan

53111

Novartis Investigative Site, Bonn

53717

Dean Health System, Madison

55407

Allina Hlth Cancer Inst Minneapolis, Minneapolis

56124

Novartis Investigative Site, Pisa

57105

Avera Cancer, Sioux Falls

60201

NorthShore University Health System, Evanston

60426

Ingalls Memorial Hospital, Harvey

60540

Edward Hospital, Naperville

60612

University of Illinois Cancer Center at Chicago, Chicago

60637

University of Chicago, Chicago

63021

Mercy Medical Research Institute, Manchester

63069

Novartis Investigative Site, Offenbach

63739

Novartis Investigative Site, Aschaffenburg

64111

St Lukes Hos Marion Bloch Neur Inst, Kansas City

69120

Novartis Investigative Site, Heidelberg

69373

Novartis Investigative Site, Lyon

69495

Novartis Investigative Site, Pierre-Bénite

72000

Novartis Investigative Site, Le Mans

72076

Novartis Investigative Site, Tübingen

72401

NEA Baptist Cancer Center, Jonesboro

72703

Highlands Oncology Group, Fayetteville

73120

Mercy Clinic Oklahoma Communities Mercy Oncology, Oklahoma City

75082

Richardson Hematology Oncology Associates, Richardson

75251

Texas Oncology, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

75702

Texas Oncology Northeast Texas, Tyler

76022

Texas Oncology P A, Bedford

76038

Novartis Investigative Site, Rouen

76104

Ctr For Cancer And Blood Disorders, Fort Worth

Texas Oncology P A, Fort Worth

77024

Texas Oncology Houston Memorial City, Houston

77030

Uni Of TX MD Anderson Cancer Cntr, Houston

77090

Millennium Research Clin Develop, Houston

78217

Texas Oncology P A, San Antonio

78503

Texas Oncology, McAllen

79110

Novartis Investigative Site, Freiburg im Breisgau

80045

Univ of Colorado School of Medicine, Aurora

80131

Novartis Investigative Site, Napoli

80335

Novartis Investigative Site, München

80501

Rocky Mountain Cancer Centers, Longmont

80756

Novartis Investigative Site, Kaohsiung City

84082

Novartis Investigative Site, Avignon

84106

Utah Cancer Specialists, Salt Lake City

85224

Ironwood Cancer and Research Centers, Chandler

86336

Arizona Oncology Associates PC HAL, Sedona

88214

Novartis Investigative Site, Ravensburg

88837

Hackensack Meridian Health, Edison

89081

Novartis Investigative Site, Ulm

89100

Novartis Investigative Site, Reggio Calabria

90025

The Angeles Clinic and Research Institute, Los Angeles

90048

Cedars Sinai Medical Center SC-5, Los Angeles

90766

Novartis Investigative Site, Fürth

91054

Novartis Investigative Site, Erlangen

91206

Glendale Adventist Medical Center, Glendale

94000

Novartis Investigative Site, Créteil

94704

Alta Bates Cancer Center, Berkeley

94800

Novartis Investigative Site, Villejuif

95817

Comprehensive Cancer Center, Sacramento

96817

Moanalua Medical Center Attn Oncology Dept, Honolulu

98158

Novartis Investigative Site, Messina

98201

Providence Regional Cancer Partnership, Everett

98405

Northwest Medical Specialties, Tacoma

163045

Novartis Investigative Site, Arkhangelsk

166830

Novartis Investigative Site, El Achrafiyé

168583

Novartis Investigative Site, Singapore

190384

Novartis Investigative Site, Cork

390011

Novartis Investigative Site, Ryazan

603000

Novartis Investigative Site, Nizhny Novgorod

4941492

Novartis Investigative Site, Petah Tikva

6423906

Novartis Investigative Site, Tel Aviv

91010 3000

City of Hope National Medical Center, Duarte

02215

Dana Farber Cancer Institute, Boston

03060

Foundation Medical Partners, Nashua

08103

Cooper Cancer Center, Camden

08901

Cancer Institute of New Jersey, New Brunswick

T4000IAK

Novartis Investigative Site, San Miguel de Tucumán

X5002AOQ

Novartis Investigative Site, Córdoba

A-1090

Novartis Investigative Site, Vienna

A-1100

Novartis Investigative Site, Vienna

14048-900

Novartis Investigative Site, Ribeirão Preto

01246 000

Novartis Investigative Site, São Paulo

01317-002

Novartis Investigative Site, São Paulo

V5G 2X6

Novartis Investigative Site, Burnaby

B3H 2Y9

Novartis Investigative Site, Halifax

L8V 5C2

Novartis Investigative Site, Hamilton

N2G 1G3

Novartis Investigative Site, Kitchener

K1H 8L6

Novartis Investigative Site, Ottawa

M4N 3M5

Novartis Investigative Site, Toronto

H2X 0A9

Novartis Investigative Site, Montreal

G1S 4L8

Novartis Investigative Site, Québec

656 53

Novartis Investigative Site, Brno

625 00

Novartis Investigative Site, Brno Bohunice

779 00

Novartis Investigative Site, Olomouc

DK-8000

Novartis Investigative Site, Aarhus

DK-2100

Novartis Investigative Site, Copenhagen

DK 5000

Novartis Investigative Site, Odense C

00029

Novartis Investigative Site, Helsinki

FIN-20520

Novartis Investigative Site, Turku

06189

Novartis Investigative Site, Nice

H-9024

Novartis Investigative Site, Győr

DO4

Novartis Investigative Site, Dublin

06129

Novartis Investigative Site, Perugia

00168

Novartis Investigative Site, Roma

05100

Novartis Investigative Site, Terni

01100

Novartis Investigative Site, Viterbo

1107 2020

Novartis Investigative Site, Beirut

6162 BG

Novartis Investigative Site, Sittard-Geleen

2333 ZA

Novartis Investigative Site, Leiden

1815 JD

Novartis Investigative Site, Alkmaar

7416 SE

Novartis Investigative Site, Deventer

9713 GZ

Novartis Investigative Site, Groningen

9728 NZ

Novartis Investigative Site, Groningen

6229 HX

Novartis Investigative Site, Maastricht

5042 AD

Novartis Investigative Site, Tilburg

NL-2722 EP

Novartis Investigative Site, Zoetermeer

8025 AB

Novartis Investigative Site, Zwolle

NO-5021

Novartis Investigative Site, Bergen

NO-0407

Novartis Investigative Site, Oslo

0081

Novartis Investigative Site, Pretoria

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

08024

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

SE-631 88

Novartis Investigative Site, Eskilstuna

413 45

Novartis Investigative Site, Gothenburg

551 85

Novartis Investigative Site, Jönköping

221 85

Novartis Investigative Site, Lund

751 85

Novartis Investigative Site, Uppsala

SE-351 85

Novartis Investigative Site, Vaxjo

06230

Novartis Investigative Site, Ankara

06590

Novartis Investigative Site, Ankara

TR1 3LJ

Novartis Investigative Site, Truro

NE7 7DN

Novartis Investigative Site, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY